UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032341 |
|---|---|
| Receipt number | R000036876 |
| Scientific Title | Prospective analysis of cardiovascular events based on titin concentration in patients with chronic heart failure |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2021/04/24 10:12:59 |
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Basic information
Public title
Prospective analysis of cardiovascular events based on titin concentration in patients with chronic heart failure
Acronym
Analysis of titin in patients with chronic heart failure
Scientific Title
Prospective analysis of cardiovascular events based on titin concentration in patients with chronic heart failure
Scientific Title:Acronym
Analysis of titin in patients with chronic heart failure
Region
| Japan |
Condition
Condition
chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the utility of analysis of titin concentration by studying the relationships between titin concentration and cardiovascular events in patients with chronic heart failure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
cardiovascular death, heart failure death, sudden cardiac death, and hospitalization due to heart failure
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Inpatients and outpatients of our hospital
(2) chronic heart failure of any severity
(3) More than 20 years old
(4) Both sex
(5) Patients with written informed concent
(6) Patients with clinically stable condition under maximally tolerable dose of standard heart failure therapy
(7) left ventricular ejection fraction of less than 40%
(8) Patients who can understand the purpose of this study
Key exclusion criteria
(1) Patients with muscular diseases (e.g. muscular dystrophy
(2) Situation of muscular destruction (e.g. strenuous training, muscle infection and so on)
(3) Patients whose life expectancy is less than 24 months
(4) Other cases who are judged to be inappropriate to be included in this study by the chief investigator.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Kensuke |
| Middle name | |
| Last name | Matsumoto |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Internal Medicine Division of Cardiovascular Medicine
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan
TEL
078-382-5846
kenmatsu@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Matsumoto |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Internal Medicine Division of Cardiovascular Medicine
Zip code
6500017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan
TEL
078-382-5846
Homepage URL
kenmatsu@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine Department of Internal Medicine Division of Cardiovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
self-sustaining
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan
Tel
078-382-6669
chiken@med.kobe-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The nature of this study is observational one. We will analyze the patients urine and measure the concentration of titin. Then, we will analyze the relationships between the concentration of titin and the patients prognosis.
Management information
Registered date
| 2018 | Year | 04 | Month | 22 | Day |
Last modified on
| 2021 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036876
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
